Development of choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) histologically diagnosed at second curettage [ Designated as safety issue: No ]

Development of "second persistent" disease, defined as failure to achieve or maintain a normal assay, or a plateau, or a rise in the assay level after second curettage [ Designated as safety issue: No ]

To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).

Secondary

To evaluate if response to a second curettage is independent of the tumor burden as measured by the quantitative beta-human chorionic gonadotropin (hCG) assay at study entry.

To evaluate if response to a second curettage is independent of the depth of myometrial invasion as measured sonographically following the initial curettage but prior to study entry (when persistent disease is first diagnosed).

To estimate the frequency of complications related to a second curettage, specifically infection of the fallopian tubes or ovaries, hemorrhage associated with curettage, or operative injury to the uterus.

To estimate the frequency of a change in the uterine histology between the first and second curettage.

OUTLINE: This is a multicenter study.

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy). Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor (histologically diagnosed at the second curettage) are removed from the study. All other patients undergo weekly beta-human chorionic gonadotropin (hCG) testing beginning 14 days after the second curettage and continuing until the beta-hCG level is normal. Patients then undergo further beta-HCG testing weekly for 4 weeks and then monthly for 5 months. If the level does not regress to normal, or rises, or if metastatic disease is identified, the patient is removed from the study.

No histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) on the first curettage

Persistent, low-risk disease (based on FIGO/WHO 2002 staging and risk scoring criteria), as defined by 1 of the following criteria:

Less than 10% decline in beta-human chorionic gonadotropin (hCG) levels, based on four consecutive measurements over a 3-week period (plateau)

Greater than 20% rise in beta-hCG levels, based on three consecutive measurements over a 2-week period

Beta-hCG level remains elevated above normal for ≥ 6 months

WHO risk score ≤ 6

Must have a clinically significant elevated beta-hCG level

Beta-hCG > 20 miu/mL

Non-metastatic disease

No evidence of metastatic disease beyond the uterus by pelvic examination, pelvic ultrasound, and chest x-ray

No previously treated, persistent or recurrent GTN (same gestation) that have been treated with chemotherapy

PATIENT CHARACTERISTICS:

GOG performance status 0-1

Fertile patients must use effective contraception during and for 6 months after completion of study therapy

No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

No prior cancer treatment that would preclude study treatment

No more than 1 prior curettage for current disease

No prior hysterectomy

No chemotherapy during the study curettage follow-up period until surgical response has been completely determined

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00521118